DGRT: Dose-Guided Radiotherapy in Oesophageal Cancer: Managing the Real Dose

Sponsor

Maastricht Radiation Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT02130011

Collaborator

Maastricht University Medical Center (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will prospectively collect patients undergoing the standard CROSS regimen in the neoadjuvant setting of the treatment for gastro-oesophageal cancer. The investigators will focus on the potential geometric differences between the OAR and target volume on the initial planning CT and on the kilovolt (kV) cone-beam computed tomography (CBCT). They expect a potential difference in the abdominal part of the planned target volume (PTV) and/or gastro-oesophageal junction part. Furthermore, the impact of gastric filling , potential tumor regression and the accuracy of 5 mm PTV margin in the thoracic PTV will be monitored.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma	Other: with feeding/fluid instruction	N/A

Detailed Description

Optimal radiotherapy planning and delivery is essential for irradiation of gastro-oesophageal junction tumors. There is a need for individualized radiotherapy delivery to the upper abdomen, because of mobility. Likewise, controlling gastric filling by instructing patients about fluid and food intake before treatment, may contribute to positional reproducibility. There is evidence that missing microscopic disease in treating the clinical target volume (CTV) results in a worse prognostic outcome. The investigators want to evaluate wether positional difference of stomach, with and without fasting prescription, has an impact of the delivered dose. They will focus on the part of the CTV extending in the stomach. The investigators hypothesize that measurement of the dose using verification kilovoltage cone beam CTs will provide information on potential cold/hot spots of dose delivery and monitor potential geometric differences during treatment. This may result in a suboptimal treatment and a reconsideration of matching target volume on soft tissue instead of bony landmarks. The investigators will evaluate the first clinical results with DGRT in patients with esophageal cancer.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Managing the Real Dose: Evaluating the Impact on Gastric Filling on the Delivered Radiation Dose in Gastrooesophageal Junction Tumors

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: without feeding/fluid instructicon Ten patients treated with preoperative chemoradiotherapy without feeding/fluid instructions
Experimental: with feeding/fluid instructions Ten patients treated with preoperative chemoradiotherapy with feeding/fluid instructions	Other: with feeding/fluid instruction No additional intervention besides standard treatment prescription will be added. Investigators foresee daily kV cone beam CT matching (already standard in house). this subgroup of 10 patients will be asked not to eat or drink carbonated fluids three hours before CT simulation and daily treatment

Arm

Intervention/Treatment

No Intervention: without feeding/fluid instructicon

Ten patients treated with preoperative chemoradiotherapy without feeding/fluid instructions

Experimental: with feeding/fluid instructions

Ten patients treated with preoperative chemoradiotherapy with feeding/fluid instructions

Other: with feeding/fluid instruction

No additional intervention besides standard treatment prescription will be added. Investigators foresee daily kV cone beam CT matching (already standard in house). this subgroup of 10 patients will be asked not to eat or drink carbonated fluids three hours before CT simulation and daily treatment

Outcome Measures

Primary Outcome Measures

Proportion of patients in which the CTV was not covered [Weekly during radio-and chemotherapy (5 weeks)]
Proportion of patients in which the CTV was not covered (CTV D99, V95, Dmean) with and without different filling status of the stomach in patients treated with neoadjuvant chemoradiotherapy for gastroesophageal cancer

Secondary Outcome Measures

Thoracic margin evaluation [weekly during radio-and chemotherapy (5weeks)]
evaluation if a CTV-PTV margin of 5 mm in the thoracic part of the target volume is sufficient
Stomach variation [Weekly during radio-and chemotherapy (5 weeks)]
stomach movement evaluation on a weekly cone beam CT during chemo radiotherapy with and without feeding/fluid instructions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically proven adenocarcinoma of the gastro-oesophageal junction
Age 18 years or older
International Union Against Cancer (UICC) T2-4 N0-2 M0, potentially resectable disease treated by the CROSS regimen
WHO 0-2

Exclusion Criteria:

Thoracic adenocarcinoma/squamous cell carcinoma
Palliative treatment for the oesophageal cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MAASTRO clinic	Maastricht		Netherlands	6229 ET

Sponsors and Collaborators

Maastricht Radiation Oncology
Maastricht University Medical Center

Investigators

Principal Investigator: Philippe Lambin, MD, PhD, Maastricht Radiation Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maastricht Radiation Oncology

ClinicalTrials.gov Identifier:

NCT02130011

Other Study ID Numbers:

DGRT
14-01-15/01-intern-6505

First Posted:

May 2, 2014

Last Update Posted:

Oct 6, 2015

Last Verified:

Oct 1, 2015

Additional relevant MeSH terms:

Adenocarcinoma

Study Results

No Results Posted as of Oct 6, 2015